Tag Archives: Roche Diagnostics

April 1, 2024—Roche announced FDA approval of the Cobas Malaria test, a qualitative in vitro nucleic acid screening test for the direct detection of Plasmodium RNA and DNA in whole blood samples from individual human donors.

March 15, 2024—Roche debuted its Navify Analytics for POC and Navify Monitoring solutions at the Healthcare Information and Management Systems Society global health conference in Orlando, March 11–15.

March 12, 2024—Roche Diagnostics announced the release of new guidelines from the American Society for Colposcopy and Cervical Pathology and other members of the Enduring Consensus Cervical Cancer Screening and Management Guidelines committee that now recognize dual-stain biomarkers as an important technology in helping clinicians triage patients to determine if their human papillomavirus infection is transforming into cervical precancer.

February 2024—Roche launched the LightCycler Pro system, designed and labeled for research and in vitro diagnostic workflows. Enhancements of this LightCycler system include a new vapor chamber for temperature uniformity across the block, new and improved software algorithms, and updated software and user interface. Users can develop their own tests or choose from a portfolio of more than 200 LightMix modular research assays and more than 60 LightMix CE-IVD assays from Roche subsidiary TIB Molbiol.

Oct. 18, 2023—Roche announced the U.S. launch of its Cobas Connection Modules Vertical, designed to help low-, mid-, and high-volume laboratories optimize space, productivity, and patient care. The CCM Vertical includes elevator units, overhead conveyors, and overhead turn units that integrate with Roche’s other CCM solutions. It transports patient samples up, down, and across and between rooms; around doorways, emergency ...

March 22, 2023—Roche has entered into a collaboration with Eli Lilly to support the development of Roche’s Elecsys Amyloid Plasma Panel.

January 2023—Roche has entered into a collaboration with Pfizer to help patients access resources and locate information about COVID-19 testing, available treatment options, high-risk factors that increase the chance of progressing to severe COVID-19, and ways to seek timely care. People can learn why early testing is important at symptom onset, which health conditions increase the risk of progressing to severe COVID-19, and what treatment options are available on covid19knowmore.com, a Pfizer website. The Pilot COVID-19 At-Home Test, distributed in the U.S. by Roche and manufactured by SD Biosensor, will include a QR code that directs people to the website.

Aug. 15, 2022—Roche announced that the FDA has approved a label expansion for the Ventana MMR RxDx panel, an immunohistochemistry companion diagnostic test to aid in identifying patients whose solid tumors are deficient in DNA mismatch repair (dMMR) and who may be eligible for Keytruda (pembrolizumab).

Nov. 18, 2021—Roche launched its Cobas 5800 system in countries accepting the CE mark.

April 23, 2021—Roche announced FDA approval of the Ventana MMR RxDx Panel for advanced or recurrent endometrial cancer patients.

April 8, 2021—Roche’s Elecsys EBV panel has launched in countries accepting the CE mark

Sept. 25, 2020—Roche announced FDA approval for the expanded use of CINtec Plus Cytology, a triage test based on biomarker technology for women whose cervical cancer screening results are positive for high-risk types of human papillomavirus.

Sept. 9, 2020—Roche received FDA 510(k) clearance for the Cobas BKV test on the Cobas 6800 and 8800 systems.

July 30, 2020—Roche announced U.S. Food and Drug Administration approval of the Ventana HER2 Dual ISH DNA Probe Cocktail assay

March 26, 2020—Roche announced FDA approval of CINtec Plus Cytology, a biomarker-based triage test for women whose primary cervical cancer screening results are positive for human papillomavirus using the Cobas 4800 HPV Test.

March  13, 2020—The FDA has issued an emergency use authorization for the Roche Cobas SARS-CoV-2. The single-well dual target assay includes specific detection of SARS-CoV-2 and pan-sarbecovirus detection for the sarbecovirus subgenus family that includes SARS-CoV-2.

February 2020—The FDA authorized marketing of the Cobas VivoDx MRSA (Roche Molecular Systems) diagnostic test based on bacterial viability and novel technology to detect methicillin-resistant Staphylococcus aureus bacterial colonization. The Cobas VivoDx MRSA test uses a new bacteriophage technology based on bioluminescence to detect MRSA from nasal swab samples in as few as five hours compared with 24 to 48 ...

Sept. 20, 2019–Roche received FDA approval for the Cobas Babesia test for use on the Cobas 6800 and Cobas 8800 systems. It is a qualitative in vitro nucleic acid screening test for the direct detection of babesia (B. microti, B. duncani, B. divergens, and B. venatorum) DNA and RNA in whole blood samples from individual human donors, including donors of whole blood and blood components, and other living donors.

July 25, 2018—The Food and Drug Administration granted breakthrough device designation to Roche’s Elecsys ß-Amyloid (1-42) CSF and Elecsys Phospho-Tau (181P) CSF. These in vitro diagnostic immunoassays are for the measurement of the ß-amyloid (1-42) and phospho-tau concentrations in cerebrospinal fluid in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease or other causes of dementia. Measuring ...

March 28, 2018—Roche launched the Ventana DP 200 high-speed slide scanner for digital pathology. The scanner features a tray-based design that enables no-touch slide processing for reduced workflow and a scan speed of less than 49 seconds for a 15-by-15 millimeter scan area. It is Digital Imaging and Communications in Medicine (DICOM) standard compatible and integrates with image management servers, ...

March 2018—Roche Diagnostics has introduced the biotinfacts.roche.com website to provide laboratorians with up-to-date data on and best practices for biotin interference. The website offers laboratorians information and answers needed to mitigate risk and help ensure patient safety.